Meetings with FDA Sample Clauses

Meetings with FDA. Without limiting the timing and conditions for the transfer of the U.S. BLA as set forth in Section 3.3 (Transfers in Connection with the U.S. BLA Transfer), prior to the U.S. BLA Transfer Date, upon Kiniksa’s reasonable request, Regeneron will request meetings with the FDA to discuss and seek guidance regarding the U.S. BLA in its current form and all information and data proposed by Kiniksa to be included with its supplemental BLA in the Kiniksa Field. Regeneron will use reasonable efforts to ensure that Regeneron personnel with relevant experience, including with respect to CMC and other Manufacturing activities related to the Product, attend such meeting with the FDA, along with Kiniksa or its designees. Regeneron’s Fully-Burdened Costs for providing services pursuant to this Section 3.2.2 (Meeting with FDA) shall be considered Other Shared Expenses.
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Meetings with FDA. Beginning on the Transfer Date through the end of the Term, to the extent practicable, Licensee shall provide [***] with prior written or email notice of all meetings, conferences and discussions that are scheduled with the FDA regarding any Licensed Product [***] after Licensee or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give AstraZeneca and Nektar a [***] to attend such meetings, conferences and discussions). For clarity, after the Transfer Date, Licensee shall not have any obligation to give Nektar or AstraZeneca the opportunity to attend meetings, conferences and discussions with the FDA that are [***], but shall use reasonable efforts to give Nektar and AstraZeneca notice as soon as practicable (whether prior to or after such meetings, conferences or discussions) of such meetings, conferences and discussions, if material. Subject to the confidentiality provisions set forth in this Agreement in Article 12, and to the extent permitted by the FDA and Applicable Laws, after the Transfer Date, Nektar and AstraZeneca shall each be entitled to have [***]. The number of representatives and the identities of such representatives to be present at any such meeting, conference or discussion shall be determined by Licensee in its good faith judgment, based solely upon considerations relating to conducting an effective interaction with the FDA. After the Transfer Date, Licensee shall not be required to account for the schedules of the Nektar or AstraZeneca representatives in scheduling such meetings, conferences or discussions except to the extent that Licensee is requiring the attendance of certain Nektar or AstraZeneca representatives, in which case Licensee shall conduct such scheduling reasonably and in good faith. AstraZeneca acknowledges that Licensee shall be the lead party and ultimately responsible for the direction of any and all regulatory interactions in the Licensed Territory except for the period prior to the Transfer Date. Licensee shall promptly forward to AstraZeneca and Nektar copies of all meeting minutes and summaries of all such meetings, conferences and discussions with any Health Authority.
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Meetings with FDA. To the extent practicable, AstraZeneca shall [***] with prior written or email notice of all meetings, conferences and discussions that are scheduled with the FDA regarding any Licensed Product [***] after AstraZeneca or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to give Nektar a [***] to attend such meetings, conferences and discussions). For clarity, AstraZeneca shall not have any obligation to give Nektar the opportunity to attend meetings, conferences and discussions with the FDA that are [***], but shall use reasonable efforts to give Nektar notice as soon as practicable (whether prior to or after such meetings, conferences or discussions) of such meetings, conferences and discussions, if material. Subject to the confidentiality provisions set forth under Article 11, and to the extent permitted by the FDA, Nektar shall be entitled to have [***]. The number of representatives and the identities of such representatives to be present at any such meeting, conference or discussion shall be determined by AstraZeneca in its good faith judgment, based solely upon considerations relating to conducting an effective interaction with the FDA. AstraZeneca shall not be required to account for the schedules of the Nektar representatives in scheduling such meetings, conferences or discussions except to the extent that AstraZeneca is requiring the attendance of certain Nektar representatives, in which case AstraZeneca shall conduct such scheduling reasonably and in good faith. AstraZeneca shall promptly forward to Nektar copies of all meeting minutes and summaries of all such meetings, conferences and discussions with the FDA.
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Meetings with FDA. AstraZeneca shall promptly provide Nektar with prior written or email notice of all meetings, conference calls, outbound calls, and any other discussions, whether scheduled or unscheduled, with the FDA regarding any Licensed Product, which notice shall be provided [***] given the projected date and time of such meeting, conference or discussion in order to give Nektar [***] to attend or otherwise participate in such meeting, conference or discussion as further described below. Subject to the
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Related to Meetings with FDA

  • Safety Meetings Accident investigation.

  • Faculty Meetings Principals shall have the authority to schedule necessary faculty meetings; however, such meetings shall be as brief and well planned as possible. Such meetings shall be used for purposes that cannot be accomplished effectively through other means. Faculty meetings shall be scheduled in a manner that impacts teacher planning time to the least degree possible. If more than one faculty meeting is held in a month, the purpose of the meeting shall be announced to the faculty in advance.

  • Joint Meetings 10.1(a) Should either party desire to discuss with the other any matter affecting generally the relationship of the parties, a meeting of Union and management representatives shall be arranged upon request of either party. Such meeting shall take place at a time mutually convenient to both parties. Any use of Company time for attendance at such meetings shall be arranged in advance by mutual agreement. 10.1(b) This Article is intended to provide a free avenue of communication between the Union and the Company, and suggestions, complaints, or other matters may be presented by either party, provided that neither party shall be required to discuss any item brought up by the other party nor be bound to act upon any item presented. However, both parties agree to discuss informal grievances and complaints.

  • Required Meetings or Hearings Whenever any employee is required to appear before the Superintendent or his designee, Board or any committee, member, representative or agent thereof concerning any matter which could adversely affect the continuation of that employee in his office, position, or employment or the salary of any increments pertaining thereto, then he shall be given prior written notice of the reasons for such meetings or interview and shall be entitled to have a representative of the Association present to advise him and represent him during such meetings or interview.

  • Management meetings 31.1 Either the Engineer or the Contractor may require the other to attend a management meeting. The business of a management meeting shall be to review the plans for remaining work and to deal with matters raised in accordance with the early warning procedure. 31.2 The Engineer shall record the business of management meetings and is to provide copies of his record to those attending the meeting and to the Employer. The responsibility of the parties for actions to be taken is to be decided by the Engineer either at the management meeting or after the management meeting and stated in writing to all who attended the meeting.

  • Open Meetings (a) All scheduled meetings of the Employer shall be open meetings, except in those cases where personnel, financial or other matters require that the meeting be considered confidential. (b) In those cases where a meeting is designated confidential, the Union shall be provided with a reason for such designation. (c) A designated member of the Union shall be provided a copy of the agenda and minutes of all open meetings. (d) Notwithstanding 18.04(b), any faculty member may request that an Union representative attend as an observer at meetings where the faculty member reasonably believes their working conditions under Article 12 will be affected. Management will be notified by the Union in advance of the meeting regarding their attendance at the meeting.

  • TAC Meetings The goal of this subtask is for the TAC to provide strategic guidance for the project by participating in regular meetings, which may be held via teleconference. • Discuss the TAC meeting schedule with the CAM at the Kick-off meeting. Determine the number and location of meetings (in-person and via teleconference) in consultation with the CAM. • Prepare a TAC Meeting Schedule that will be presented to the TAC members during recruiting. Revise the schedule after the first TAC meeting to incorporate meeting comments. • Prepare a TAC Meeting Agenda and TAC Meeting Back-up Materials for each TAC meeting. • Organize and lead TAC meetings in accordance with the TAC Meeting Schedule. Changes to the schedule must be pre-approved in writing by the CAM. • Prepare TAC Meeting Summaries that include any recommended resolutions of major TAC issues. • Help set the project team's goals and contribute to the development and evaluation of its statement of proposed objectives as the project evolves. • Provide a credible and objective sounding board on the wide range of technical and financial barriers and opportunities. • Help identify key areas where the project has a competitive advantage, value proposition, or strength upon which to build. • Advocate on behalf of the project in its effort to build partnerships, governmental support and relationships with a national spectrum of influential leaders. • Ask probing questions that insure a long-term perspective on decision-making and progress toward the project’s strategic goals. • Review and provide comments to proposed project performance metrics. • Review and provide comments to proposed project Draft Technology Transfer Plan. • TAC Meeting Schedule (draft and final) • TAC Meeting Agendas (draft and final) • TAC Meeting Back-up Materials • TAC Meeting Summaries

  • Labour Management Meetings The committee meeting shall normally be held every second month however, either party may call a meeting of the Joint Labour Management Committee. The meeting shall be held at a time and place fixed by mutual agreement but no later than fourteen (14) calendar days after the initial request, unless mutually agreed.

  • Meetings Meetings of the Trustees shall be held from time to time upon the call of the Chairman, if any, or the President or any two Trustees. Regular meetings of the Trustees may be held without call or notice at a time and place fixed by the By-Laws or by resolution of the Trustees. Notice of any other meeting shall be given by the Secretary and shall be delivered to the Trustees orally not less than 24 hours, or in writing not less than 72 hours, before the meeting, but may be waived in writing by any Trustee either before or after such meeting. The attendance of a Trustee at a meeting shall constitute a waiver of notice of such meeting except where a Trustee attends a meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting has not been properly called or convened. Any time there is more than one Trustee, a quorum for all meetings of the Trustees shall be one-third, but not less than two, of the Trustees. Unless provided otherwise in this Declaration and except as required under the 1940 Act, any action of the Trustees may be taken at a meeting by vote of a majority of the Trustees present (a quorum being present) or without a meeting by written consent of a majority of the Trustees. Any committee of the Trustees, including an executive committee, if any, may act with or without a meeting. A quorum for all meetings of any such committee shall be one-third, but not less than two, of the members thereof. Unless provided otherwise in this Declaration, any action of any such committee may be taken at a meeting by vote of a majority of the members present (a quorum being present) or without a meeting by written consent of all of the members. With respect to actions of the Trustees and any committee of the Trustees, Trustees who are Interested Persons in any action to be taken may be counted for quorum purposes under this Section and shall be entitled to vote to the extent not prohibited by the 1940 Act. All or any one or more Trustees may participate in a meeting of the Trustees or any committee thereof by means of a conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other; participation in a meeting pursuant to any such communications system shall constitute presence in person at such meeting.

  • Closed Meetings The Board and Board committees may meet in a closed meeting to consider the following subjects:

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